K843812 is an FDA 510(k) clearance for the WOODLYN CLASSIC CATARACT ACUITY TEST. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on December 11, 1984, 74 days after receiving the submission on September 28, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K843812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1984 |
| Decision Date | December 11, 1984 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLI — Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |